—#43150

Product

Depuy brand Acclaim Elbow linked ulnar bearing assembly (ulnar bearing and locking screw), sterile; catalog # 1722-63-000.

FDA product code: JDB — Prosthesis, Elbow, Semi-Constrained, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K992656
Affected lot / code info: All units.

Why it was recalled

The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via letter dated 11/10/05 and asked to return product.

Recalling firm

Firm: Depuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Nationwide, Argentina, Ireland, New Zealand and Spain.

Timeline

Recall initiated: 2005-11-08
Posted by FDA: 2006-02-16
Terminated: 2006-06-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43150. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.